COMMITTED TO FDA GUIDELINES
AND AATB STANDARDS

The safety of our products and technologies is our main priority. RegenTX maintains a current FDA establishment registration and listing for all manufactured products for packaging, processing, storage, labeling and distribution. We also hold an accreditation with the American Association of Tissue Banks.

View Certificates

SAFETY

FDA REGISTRATION

AMERICAN ASSOCIATION OF TISSUE BANKS

HUMAN CELL AND TISSUE PRODUCTS

RegenTX manufactures human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act) as described in 21 CFR 1271.10.

All products manufactured by RegenTX meet the following criteria:

  1. The HCT/P is minimally manipulated;
  2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
  3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
  4. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function.
Contact us

STEWARDS OF THE GIFT OF DONATION

At RegenTX, we engage with external recovery partners for donor authorization/informed consent and recovery, collection, and/or acquisition of donated human tissue.
As we hold the safety and quality of our products to the highest Standard, we only engage with recovery partners who maintain compliance with FDA 21 CFR 1271 and AATB standards. Our partners are committed to providing stewardship for the gift of donated human tissue and to taking the utmost care in the recovery, collection, and/or acquisition process.

Contact us

RESPECTING THE DONORS
AND THEIR FAMILIES

Donors and/or their families are gently approached and educated on the opportunity for donation. After authorization/informed consent for donation is obtained, recovery, collection, or acquisition is performed using aseptic or clean techniques appropriate to the specific tissue type and intended use.
All donors are carefully evaluated in accordance with FDA and AATB standards for considerable risk behaviors and relevant communicable diseases to ensure safety of the donated tissue.

Contact us

QUALITY ASSURANCE PROGRAM GUARANTEES SAFETY

Since we recognize the instrumental role that quality holds to ensure the safety of our products, we have worked hard to build a strong quality system and team. All policies and procedures are designed to meet or exceed FDA requirements under 21 CFR 1271 and AATB Standards. Our Quality Assurance Program oversees quality event management, document control, record management, validation/qualification activities, quality/labeling/purchasing control, training, and reviews, approval, and release of donor records and batch records.

Quality is built into our critical processes and support activities to provide evidence and verification of compliance.Our experienced quality team works to ensure that the entire operation is in conformity with the FDA regulations, AATB standards, and internal procedures. The suitability and effectiveness of the quality system is routinely evaluated at defined intervals.

Contact us

We look forward to telling you more about our exciting company.

If you are interested in collaborating with us, please get in touch.